MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. Medline Industries, Inc.; ANESTHESIA CIRCUIT EXP-LF

Model Number DYNJAA10640

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the anesthesia circuit disconnected during patient use.When this occurred, the clinician user indicated that the originally planned method of anesthesia induction was changed to a different one.The clinician end-user indicated that there was no adverse patient impact related to the incident.No sample was returned to the manufacturer for evaluation.A root cause was unable to be determined at this time.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the anesthesia circuit disconnected during patient use.

• Brand Name: Medline Industries, Inc.
• Type of Device: ANESTHESIA CIRCUIT EXP-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12474859
• MDR Text Key: 277721192
• Report Number: 1417592-2021-00174
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10889942801275
• UDI-Public: 10889942801275
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJAA10640
• Device Catalogue Number: DYNJAA10640
• Device Lot Number: 21FBK886
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention